NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM
FDA 510(k) clearance K042384 · decided 2005-03-29
Clearance details
- K-number
- K042384
- Device name
- NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM
- Applicant
- Cyberkinetics, Inc. (Cki)
- Decision
- Substantially Equivalent
- Date received
- 2004-09-01
- Decision date
- 2005-03-29
- Days to decision
- 209 days
- Clearance type
- Traditional
- Product code
- GZL
- Device class
- 2
- Regulation number
- 882.1330
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Inserter Wand Holder, Non-Sterile, Serial # 4273-0000, Blackrock Microsystems, Salt Lake C recall (Z-1619-2010) | I2s Micro Implantable Systems Llc | 2010-05-20 |
| Cyberkinetics Inserter Wand & V2 Trigger Assembly, Expiration: July 14, 2009; Catalog Numb recall (Z-1553-2009) | Cyberkinetics Neurotechnology Systems, Inc. | 2009-07-07 |